NCT03251547

Brief Summary

This is a retrospective descriptive study, to study the treatment indications, changes in transfusion need, coagulation profiles changes and clinical outcome (survival, complication) of non-haemophiliac patients who received activated factor seven (rFVIIa / NovoSeven®) during massive bleeding in Hospital Universiti Sains Malaysia (HUSM)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

August 21, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

August 11, 2017

Last Update Submit

October 9, 2018

Conditions

Massive HemorrhageMassive Blood LossMassive Blood Transfusion; Thrombocytopenia

Keywords

rFVIIaMassive Hemorrhagenon-hemophilia

Outcome Measures

Primary Outcomes (2)

  • Changes in blood transfusion requirement

    To study the changes in blood product requirement in 24 hours before and after administration of rFVIIa in massive bleeding patient in HUSM and to describe the factors affecting it.

    24 hour before and after administration of rFVIIa

  • Survival rate

    To describe the outcome of survival at 24-hour and Day-30 after receiving rFVIIa

    30 days

Secondary Outcomes (1)

  • Changes in coagulation profile

    24 hour before and after administration of rFVIIa

Other Outcomes (1)

  • Complication rate

    30 days

Study Arms (1)

NovoSeven

Non-hemophiliac patients experienced massive haemorrhage who was treated with recombinant activated factor VII

Drug: NovoSeven

Interventions

NovoSevenDRUG

To survey retrospectively the treatment indications, clinical outcome, transfusion need and changes in coagulation profiles of non-haemophiliac patients who had received rFVIIa during massive bleeding

Also known as: recombinant activated factor VII
NovoSeven

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Non-haemophilic patients who had received rFVIIa during massive bleeding in Hospital Universiti Sains Malaysia (HUSM)

You may qualify if:

  • All patient with massive bleeding who had received rFVIIa from year 2006 to year 2016.
  • Massive bleeding criteria
  • Loss of one blood volume within a 24 hour
  • % blood volume loss within 3 h
  • Rate of loss of 150 ml/min

You may not qualify if:

  • Haemophilia patient who received rFVIIa
  • Poor documentation / record unavailable in HUSM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Location

Related Publications (12)

  • Hunt BJ. Bleeding and coagulopathies in critical care. N Engl J Med. 2014 Feb 27;370(9):847-59. doi: 10.1056/NEJMra1208626. No abstract available.

    PMID: 24571757BACKGROUND

  • Bougle A, Harrois A, Duranteau J. Resuscitative strategies in traumatic hemorrhagic shock. Ann Intensive Care. 2013 Jan 12;3(1):1. doi: 10.1186/2110-5820-3-1.

    PMID: 23311726BACKGROUND

  • Cosgriff N, Moore EE, Sauaia A, Kenny-Moynihan M, Burch JM, Galloway B. Predicting life-threatening coagulopathy in the massively transfused trauma patient: hypothermia and acidoses revisited. J Trauma. 1997 May;42(5):857-61; discussion 861-2. doi: 10.1097/00005373-199705000-00016.

    PMID: 9191667BACKGROUND

  • Faraoni D, Van Der Linden P. A systematic review of antifibrinolytics and massive injury. Minerva Anestesiol. 2014 Oct;80(10):1115-22. Epub 2013 Nov 28.

    PMID: 24287671BACKGROUND

  • Franchini M. The use of desmopressin as a hemostatic agent: a concise review. Am J Hematol. 2007 Aug;82(8):731-5. doi: 10.1002/ajh.20940.

    PMID: 17492648BACKGROUND

  • Kobayashi T, Nakabayashi M, Yoshioka A, Maeda M, Ikenoue T. Recombinant activated factor VII (rFVIIa/NovoSeven(R)) in the management of severe postpartum haemorrhage: initial report of a multicentre case series in Japan. Int J Hematol. 2012 Jan;95(1):57-63. doi: 10.1007/s12185-011-0974-9. Epub 2011 Dec 9.

    PMID: 22160834BACKGROUND

  • Lin Y, Moltzan CJ, Anderson DR; National Advisory Committee on Blood and Blood Products. The evidence for the use of recombinant factor VIIa in massive bleeding: revision of the transfusion policy framework. Transfus Med. 2012 Dec;22(6):383-94. doi: 10.1111/j.1365-3148.2012.01164.x. Epub 2012 May 27.

    PMID: 22630348BACKGROUND

  • Logan AC, Goodnough LT. Recombinant factor VIIa: an assessment of evidence regarding its efficacy and safety in the off-label setting. Hematology Am Soc Hematol Educ Program. 2010;2010:153-9. doi: 10.1182/asheducation-2010.1.153.

    PMID: 21239786BACKGROUND

  • Palmason R, Vidarsson B, Sigvaldason K, Ingimarsson JP, Gudbjartsson T, Sigurdsson GH, Onundarson PT. Recombinant factor VIIa as last-resort treatment of desperate haemorrhage. Acta Anaesthesiol Scand. 2012 May;56(5):636-44. doi: 10.1111/j.1399-6576.2012.02688.x.

    PMID: 22489992BACKGROUND

  • Spahn DR, Bouillon B, Cerny V, Coats TJ, Duranteau J, Fernandez-Mondejar E, Filipescu D, Hunt BJ, Komadina R, Nardi G, Neugebauer E, Ozier Y, Riddez L, Schultz A, Vincent JL, Rossaint R. Management of bleeding and coagulopathy following major trauma: an updated European guideline. Crit Care. 2013 Apr 19;17(2):R76. doi: 10.1186/cc12685.

    PMID: 23601765BACKGROUND

  • Stainsby D, MacLennan S, Hamilton PJ. Management of massive blood loss: a template guideline. Br J Anaesth. 2000 Sep;85(3):487-91. doi: 10.1093/bja/85.3.487.

    PMID: 11103199BACKGROUND

  • Yank V, Tuohy CV, Logan AC, Bravata DM, Staudenmayer K, Eisenhut R, Sundaram V, McMahon D, Olkin I, McDonald KM, Owens DK, Stafford RS. Systematic review: benefits and harms of in-hospital use of recombinant factor VIIa for off-label indications. Ann Intern Med. 2011 Apr 19;154(8):529-40. doi: 10.7326/0003-4819-154-8-201104190-00004.

    PMID: 21502651BACKGROUND

MeSH Terms

Conditions

Thrombocytopenia

Interventions

recombinant FVIIa

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Study Officials

  • Chong Soon Eu, MD, MMed

    Universiti Sains Malaysia

    STUDY CHAIR

  • Nurfatin Mohd Shah, BSc

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 11, 2017

First Posted

August 16, 2017

Study Start

August 21, 2017

Primary Completion

October 15, 2017

Study Completion

November 15, 2017

Last Updated

October 10, 2018

Record last verified: 2018-10

Locations

MY(1)